MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305767
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x1-1/2 rb needle clogged/blocked it was reported by customer that they are currently having a problem with our 25-gauge injection needles.We will draw the solution to be injected switch needles to the 25-gauge needle with a safety cap.The issue that is happening is the solution will not push thru the needle, no matter how hard it is pushed.We then have to switch out the needle again.I have had to stick a patient 3 times because the 1st 2 needles the solution could not be pushed thru.Verbatim: we are currently having a problem with our 25-gauge injection needles.We will draw the solution to be injected switch needles to the 25-gauge needle with a safety cap.The issue that is happening is the solution will not push thru the needle, no matter how hard it is pushed.We then have to switch out the needle again.I have had to stick a patient 3 times because the 1st 2 needles the solution could not be pushed thru.Ref # is 305767.
Additional Manufacturer Narrative
Other reported issue of needle clogged/ blocked was not confirmed upon inspection of the samples.Analysis of the samples showed no clogged needle.No other defects or damages were observed on the samples.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this lot meets our manufacturing specification requirements.The root cause could not be determined as the defect could not be replicated.
Event or Problem Description
Material #:305767; batch#:unknown.It was reported by customer that they are currently having a problem with our 25-gauge injection needles.We will draw the solution to be injected switch needles to the 25-gauge needle with a safety cap.The issue that is happening is the solution will not push thru the needle, no matter how hard it is pushed.We then have to switch out the needle again.I have had to stick a patient 3 times because the 1st 2 needles the solution could not be pushed thru.We are currently having a problem with our 25-gauge injection needles.We will draw the solution to be injected switch needles to the 25-gauge needle with a safety cap.The issue that is happening is the solution will not push thru the needle, no matter how hard it is pushed.We then have to switch out the needle again.I have had to stick a patient 3 times because the 1st 2 needles the solution could not be pushed thru.Ref # is (b)(4).

• Brand Name: BD NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20108735
• Report Number: 2243072-2024-00940
• Device Sequence Number: 7794762
• Product Code: FMI
• UDI-Device Identifier: 00382903057672
• UDI-Public: (01)00382903057672
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305767
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown